FDA Issues Public Health Advisory on Vioxx as its Manufacturer Voluntarily Withdraws the Product The Food and Drug Administration (FDA) today acknowledged the voluntary withdrawal from the market of Vioxx (chemical name rofecoxib), a non-steroidal anti-inflammatory drug (NSAID) manufactured by Merck & Co. FDA today also issued a Public Health Advisory to inform patients of this action and to advise them to consult with a physician about alternative medications. Merck is withdrawing Vioxx from the market after the data safety monitoring board overseeing a long-term study of the drug recommended that the study be halted because of an increased risk of serious cardiovascular events, including heart attacks and strokes, among study patients taking Vioxx compared to patients receiving placebo. The study was being done in patients at risk of developing recurrent colon polyps. "Merck did the right thing by promptly reporting these findings to FDA and voluntarily withdrawing the product from the market," said Acting FDA Commissioner Dr. Lester M. Crawford. "Although the risk that an individual patient would have a heart attack or stroke related to Vioxx is very small, the study that was halted suggests that, overall, patients taking the drug chronically face twice the risk of a heart attack compared to patients receiving a placebo." Dr. Crawford added that FDA will closely monitor other drugs in this class for similar side effects. "All of the NSAID drugs have risks when taken chronically, especially of gastrointestinal bleeding, but also liver and kidney toxicity. They should only be used continuously under the supervision of a physician." FDA approved Vioxx in 1999 for the reduction of pain and inflammation caused by osteoarthritis, as well as for acute pain in adults and for the treatment of menstrual pain. It was the second of a new kind of NSAID (Cox-2 selective) approved by FDA. Subsequently, FDA approved Vioxx to treat the signs and symptoms of rheumatoid arthritis in adults and children. At the time that Vioxx and other Cox-2 selective NSAIDs were approved, it was hoped that they would have a lower risk of gastrointestinal ulcers and bleeding than other NSAIDs (such as ibuprofen and naproxen). Vioxx is the only NSAID demonstrated to have a lower rate of these side effects. Merck contacted FDA on September 27, 2004, to request a meeting and to advise the agency that the long-term study of Vioxx in patients at increased risk of colon polyps had been halted. Merck and FDA officials met the next day, September 28, and during that meeting the company informed FDA of its decision to remove Vioxx from the market voluntarily. In June 2000, Merck submitted to FDA a safety study called VIGOR (Vioxx Gastrointestinal Outcomes Research) that found an increased risk of serious cardiovascular events, including heart attacks and strokes, in patients taking Vioxx compared to patients taking naproxen. After reviewing the results of the VIGOR study and other available data from controlled clinical trials, FDA consulted with its Arthritis Advisory Committee in February 2001 regarding the clinical interpretation of this new safety information. In April 2002, FDA implemented labeling changes to reflect the findings from the VIGOR study. The labeling changes included information about the increase in risk of cardiovascular events, including heart attack and stroke. Recently other studies in patients taking Vioxx have also suggested an increased risk of cardiovascular events. FDA was in the process of carefully reviewing these results, to determine whether further labeling changes were warranted, when Merck informed the agency of the results of the new trial and its decision to withdraw Vioxx from the market. Additional information about this withdrawal of Vioxx, as well as questions and answers for patients, is available online at FDA Press Release
Injectable Anesthesia Drug Being Withdrawn From Market The injectable anesthesia drug RAPLON (rapacuronium bromide) is being voluntarily withdrawn from the market after its manufacturer received reports indicating that the drug may be associated with bronchospasm - a mild to severe inability to breathe normally that can lead to permanent injury or death. Five deaths, reported to the manufacturer, occurred during the administration of Raplon. The drug™s sponsor, Organon Inc., of West Orange, N.J., contacted FDA and sent a letter beginning March 27, 2001, to all anesthesiologists, hospital pharmacists, and other consignees of the drug, notifying them of the voluntary withdrawal of the drug and providing information on how to return unused inventory back to the company. RAPLON was administered in hospital and other surgical settings as a muscle relaxant for breathing tube placement and surgery. Other drugs on the market may be prescribed for the same purpose, and this withdrawal does not affect the overall availability of anesthesiology drugs. FDA approved RAPLON for this indication in August 1999 after more than a yearlong review of Organon™s new drug application. Although the drugs approved labeling did note the occurrence of bronchospasm in a small percentage of clinical trial patients receiving the drug, post- marketing reports indicate that the risk of injury from bronchospasm may be greater than was suggested in clinical trials. Patients and healthcare providers with questions about this product withdrawal can contact the company at Customer Service 1-800-241-8812, or through FDA™s MedWatch page at www.fda.gov/medwatch.
Reports of deaths associated with QT prolongation and torsades de pointes in patients treated with doses of INAPSINE (droperidol) above, within and even below the approved range have prompted Akorn to revise sections of the prescribing information, specifically 1) WARNINGS (including a new Box Warning) which call attention to the potential for serious morbidity and mortality, 2) INDICATIONS which reinforces the appropriate patient population for whom this product is intended, and 3) DOSAGE AND ADMINISTRATION which clarifies the available dosing information. There have been a number of reports of patients who have been treated with droperidol and who developed suspected or established torsades de pointes, at times leading to death. There have been additional cases of symptomatic arrhythmia associated with a prolonged QT interval after droperidol administration that have been submitted via ongoing safety surveillance activities. In addition, clinical investigators have reported a dose-related increase in QT prolongation with droperidol and replication of cardiac changes in a patient rechallenged with droperidol. Therefore, Acorn, Inc. has made important changes to the INAPSINE label. The labeling changes will be implemented within the next several weeks. In the meantime, we want you to be aware of this important safety information. Listed below are highlights of important changes to WARNINGS and INDICATIONS. You should consult the full prescribing information accompanying this letter for all of the changes. The following BOX WARNING has been added: WARNING Cases of QT prolongation and/or torsades de pointes have been reported in patients receiving INAPSINE at doses at or below recommended doses. Some cases have occurred in patients with no known risk factors for QT prolongation and some cases have been fatal. Due to its potential for serious proarrhythmic effects and death, INAPSINE should be reserved for use in the treatment of patients who fail to show an acceptable response to other adequate treatments, either because of insufficient effectiveness or the inability to achieve an effective dose due to intolerable adverse effects from those drugs (see Warnings, Adverse Reactions, Contraindications, and Precautions). Cases of QT prolongation and serious arrhythmias (e.g., torsades de pointes) have been reported in patients treated with INAPSINE. Based on these reports, all patients should undergo a 12-lead ECG prior to administration of INAPSINE to determine if a prolonged QT interval (i.e., QTc greater than 440 msec for males or 450 msec for females) is present. If there is a prolonged QT interval, INAPSINE should NOT be administered. For patients in whom the potential benefit of INAPSINE treatment is felt to outweigh the risks of potentially serious arrhythmias, ECG monitoring should be performed prior to treatment and continued for 2-3 hours after completing treatment to monitor for arrhythmias. INAPSINE is contraindicated in patients with known or suspected QT prolongation, including patients with congenital long QT syndrome. INAPSINE should be administered with extreme caution to patients who may be at risk for development of prolonged QT syndrome (e.g., congestive heart failure, bradycardia, use of a diuretic, cardiac hypertrophy, hypokalemia, hypomagnesemia, or administration of other drugs known to increase the QT interval). Other risk factors may include age over 65 years, alcohol abuse, and use of agents such as benzodiazepines, volatile anesthetics, and IV opiates. Droperidol should be initiated at a low dose and adjusted upward, with caution, as needed to achieve the desired effect This is also reinforced in WARNINGS, as well as in CONTRAINDICATIONS. The INDICATIONS AND USAGE section now reads: INAPSINE (droperidol) is indicated to reduce the incidence of nausea and vomiting associated with surgical and diagnostic procedures. The DOSAGE AND ADMINISTRATION SECTION now reads: Dosage should be individualized. Some of the factors to be considered in determining the dose are age, body weight, physical status, underlying pathological condition, use of other drugs, type of anesthesia to be used and the surgical procedure involved. Vital signs and ECG should be monitored routinely. Adult dosage: The maximum recommended initial dose of INAPSINE is 2.5 mg IM or slow IV. Additional 1.25 mg doses of INAPSINE may be administered to achieve the desired effect. However, additional doses should be administered with caution, and only if the potential benefit outweighs the potential risk. Children's dosage: For children two to 12 years of age, the maximum recommended initial dose is 0.1 mg/kg, taking into account the patient's age and other clinical factors. However, additional doses should be administered with caution and only if the potential benefit outweighs the potential risk. It is important that you forward any adverse event information associated with the use of droperidol to Akorn at 1-888-519-8384. You can also report this information directly to the FDA via the MedWatch system at 1-800-FDA-1088, by fax at 1-800-FDA-0178, by mail (using a postage-paid form), or the internet at www.fda.gov/medwatch.
Handhelds and Healthcare Innovation Healthcare organizations are turning to Handheld computers to streamline business processes and improve overall patient care. Using Palm handheld computers, healthcare providers can access and manage critical information at the point of care, where decision support is so critical. Palm's focus on promoting solutions that assist in addressing critical healthcare issues -- patient safety, quality of care, decision support, HIPAA compliance, security -- has made the company a leading handheld provider for the healthcare industry. And because the open, flexible platform integrates easily with existing technology infrastructures, Palm handhelds also have become the preferred choice among healthcare administrators and IT managers. Jackson Memorial Hospital Extends Handheld Strategy Jackson Memorial Hospital, the teaching hospital for the University of Miami School of Medicine, hosts the nation's largest residency program for training anesthesiologists. Recently, the hospital began the first phase of a handheld initiative, purchasing 150 Palm handhelds for the residents, faculty and staff of the anesthesiology department. The first project was the conversion of paper-based clinical guidelines, such as the American College of Cardiology (ACC) and American Heart Association (AHA) recommendations, into interactive guidelines for the Palm handheld. Jackson Memorial Hospital uses Gothic Software's Residency Partner, a custom software program that provides a comprehensive approach to tracking a resident's education, to track the resident's clinical experiences via Palm OS based applications. The department plans to use the handhelds for decision support and will deploy interactive applications focused on education, research support and clinical care, enabling access to critical information at the point of patient care. "We are continuously exploring ways to integrate technology into the clinical environment in order to develop better ways to treat our patients, train our residents, and better utilize available data," said Thomas Powell, M.D., director of Anesthesia Information Systems for the Department of Anesthesia, Perioperative Medicine, and Pain Management at Jackson Memorial. "Palm handhelds are an important part of the future of healthcare informatics. We chose Palm because of its stability and commitment to supporting technology solutions that aim to make the practice of medicine more efficient and better for organizations and patients alike." eAnesthesiaSoftware Develops Solutions to Streamline Efficiencies for Anesthesia Providers Anesthesia providers can see up to 10 patients on an average day. Each patient record requires a minimum of four reports: the patient's anesthesia record, billing information, medication instructions and quality assurance. Previously, providers had to complete all four reports manually, laden with duplicate data, and hand-deliver them to the pharmacy and billing departments. Now, using eAnesthesiaSoftware MOSES, the provider has to input the information only once, and the software automatically updates all four reports and electronically delivers patient data to the appropriate departments. Not only does this streamline administrative functions, but it also creates a uniform standard for reporting. Billing, pharmacy and administrative offices no longer have to call the provider to get clarification on medication or patient instructions due to poor handwriting or misplaced forms. Running on a Palm handheld, which fits comfortably in a lab coat pocket, the MOSES software provides mobility and ease of use for time-crunched medical professionals who are often running back and forth between pre-operative care, surgery and recovery. "By removing the paper-based redundancies and streamlining reporting and billing procedures, the anesthesia provider can spend more time focusing on patient safety. In our business, that's the one thing that matters most," said John Michael Borza, president and chief executive officer of Pittsburgh-based eAnesthesiaSoftware.
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